Phase 2 Study of Epcoritamab with Second-Generation BTK Inhibitors With or Without Obinutuzumab for Treating CLL and SLL Variants

What this Trial Is About

Researchers are evaluating the use of Epcoritamab as a consolidation therapy for patients with chronic lymphocytic leukemia CLL or small lymphocytic lymphoma SLL, including related variants, who have previously received second-generation BTK inhibitors BTKi with or without Obinutuzumab. This phase 2, multicenter study aims to determine whether up to 12 cycles of subcutaneous Epcoritamab following at least 12 months of BTKi therapy can increase complete remission rates with undetectable minimal residual disease uMRD, potentially allowing patients to stop therapy and achieve durable remission. The study also investigates the immune response involving the patients own T-cells after treatment. Participants receive Epcoritamab combined with their ongoing oral BTKi therapy. The dosing starts with step-up doses during the first cycle to determine the recommended dose, followed by regular doses across cycles 2 to 12. Epcoritamab is given subcutaneously on specified days within each 28-day cycle, with the oral BTKi taken daily throughout. Disease response is assessed after cycles 6 and 12 using blood tests, CT scans, and bone marrow biopsies if indicated, including tests for minimal residual disease using next-generation sequencing. During the study, participants undergo various evaluations such as laboratory tests, imaging scans, bone marrow biopsies, and flow cytometry to monitor disease status and immune cell levels. Safety is tracked using standard criteria throughout treatment and for 60 days after the last dose. After completing 12 cycles of Epcoritamab, patients may continue their BTKi therapy alone based on discussions with their doctor. The total study period for each participant is approximately one year, with ongoing assessments to measure remission and survival outcomes.

Study of Epcoritamab as a Consolidation Therapy in CLL/SLL